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Completed

NCT Number: NCT05368376

Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries?

Background: Mucosal bleeding is the most frequent complication with endoscopic nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, leading to increased complications, operation duration, and blood loss. There are several pharmacological techniques for the appropriate control of intraoperative bleeding.

Objectives: To compare the safety and efficacy of oral labetalol versus oral metoprolol as a premedication for controlled hypotensive anesthesia during endoscopic nasal surgeries.

Patients and Methods: This is a randomized, double-blind, phase four, comparative clinical trial; carried out on 60 patients, who were candidates for endoscopic nasal surgeries under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group L, received oral labetalol, and group M, received oral metoprolol.

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Key information

Conditions

Hypotension Drug-Induced Cardiovascular Diseases Hypotension Vascular Diseases

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status ≤ II
  • Age from 21 to 50 years
  • Body Mass Index (BMI) ≤ 35 kg/m2

Exclusion criteria

  • ASA physical status > II
  • Age < 21 years or > 50 years
  • Pregnant women
  • Breastfeeding
  • Bronchial asthma
  • Chronic obstructive pulmonary disease
  • Hypertension
  • Ischemic heart disease
  • Rheumatic heart disease
  • Heart failure
  • Heart block
  • Sick sinus syndrome
  • Sinus bradycardia
  • Chronic hypotension
  • Anemia (Hb < 10 g/dl)
  • Renal or hepatic dysfunction
  • Central nervous system disease
  • Bleeding diathesis
  • Diabetes Mellitus
  • Allergic fungal sinusitis
  • Patients on beta-blockers, tricyclic antidepressants, alcohol or drug abuse, anticoagulation therapy, agents influencing the autonomic nervous system
  • Patients using pacemakers
  • Allergy to the study drugs
  • Any contraindication of oral intake

Treatment and study plan

Labetalol Hydrochloride Oral Tablet

Drug

Labetalol 200 mg

Other names: Labipress tablets

Metoprolol Tartrate Oral Tablet

Drug

Metoprolol 100 mg

Other names: Betaloc tablets

Primary outcomes

  1. Mean and Standard deviation of Blood loss (ml)(mean±SD)

    Time frame: 30 minutes after the end of surgery

    Amount of blood loss at the end of surgery

Secondary outcomes

  1. Mean and Standard deviation of Sevoflurane concentration (%)(mean±SD)

    Time frame: 30 minutes after the end of surgery

    Concentration of sevoflurane used during surgery

  2. Mean and Standard deviation of Heart rate (beat/min.)(mean±SD)

    Time frame: 30 minutes after the end of surgery

    Before premedication (T_B), 2 hours after premedication (T0), 1 minute after induction of anesthesia (T1), at 15 (T15), 30 (T30), 45 (T45), 60 (T60), 75 (T75) minutes after induction of anesthesia, at post anesthesia care unit (T_PACU)

  3. Mean and Standard deviation of Mean Blood Pressure (mmHg)(mean±SD)

    Time frame: 30 minutes after the end of surgery

    Before premedication (T_B), 2 hours after premedication (T0), 1 minute after induction of anesthesia (T1), at 15 (T15), 30 (T30), 45 (T45), 60 (T60), 75 (T75) minutes after induction of anesthesia, at post anesthesia care unit (T_PACU)

  4. Number of participants and Percentage of Drug-related side effects

    Time frame: 30 minutes after the end of surgery

    Number of participants and Rate of: Bradycardia, Hypotension, Dysrhythmia, Bronchospasm, and Postoperative nausea and vomiting (PONV)

Sponsors and collaborators

Lead sponsor

Damanhour Teaching Hospital

Other Gov

Registry information

Official study title

Is Labetalol More Effective Than Metoprolol for Controlled Hypotensive Anesthesia During Endoscopic Nasal Surgeries? A Randomized Clinical Trial.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 10, 2022
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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